Comments due mid-February for Sunshine Act proposed rule change on physician payments
Less than a week before Christmas, the Centers for Medicare & Medicaid Services (CMS) dispatched a proposal. CMS published proposed regulations for the Sunshine Act on physician payments regarding relationships beginning Jan. 1, with comments due by close of business on Friday, Feb. 17.
“The proposed rule provides details on the process and requirements for the reporting of payments made by pharmaceutical, biological, medical device and medical supply manufacturers to physicians and teaching hospitals, and also the reporting of financial relationships between physicians, manufacturers and group purchasing organizations, also known as GPOs,” explained Kim Kannensohn, a healthcare attorney and partner with McGuireWoods law firm, specializing in healthcare. “The proposed rule includes an announcement that applicable manufacturers and GPOs won’t be required to collect payment information and information regarding financial relationships beginning Jan. 1. Rather, such collection will be required only after CMS publishes a final rule. CMS is seeking comments on how much time reporting entities will need, following publication of the final rule, to begin complying with the data collection requirements of the Sunshine Act.”
In the proposed rule, CMS addresses a number of the issues that concerned stakeholders following the promulgation of the Sunshine Act, said Krist Werling, also a healthcare attorney and partner with McGuireWoods.
“Specifically in the regulation, CMS proposes to maintain as two separate reporting requirements the obligation of applicable manufacturers to report transfers of value to covered recipients and the obligation of applicable manufacturers and GPOs to identify physician investors and to report transfers of value to such individuals, even though there may be some duplication of information in the reports,” said Werling, pointing out four other components of the proposal:
Allowing applicable manufacturers to provide a description of the assumptions used to categorize payments such as travel, meals and speakers’ fees in conjunction the submission of their annual reports.
Defining GPOs to include physician-owned distributorships (PODs) to fulfill the requirement to identify physician investors and report certain payments to these individuals.
Exempting from disclosure under the Freedom of Information Act payments related to research or development of new devices, drugs, biological or medical supplies – and new applications of existing products – where the payments are subject to delayed publication because of the need to maintain the confidentiality of proprietary information.
Imposing civil monetary penalties upon applicable manufacturers not simply for failing to report payments in a timely manner, but also for failing to furnish accurate and complete information.
“In promulgating the proposed rule, CMS took into account stakeholder feedback from the Open Door Forum it held on March 24, 2011, as well as guidance obtained through consultation with the Office of the Inspector General of the Department of Health and Human Services,” said Holly Carnell, a healthcare attorney and McGuireWoods associate. “Generally, CMS is proposing to retain the statutory definitions set forth in the Sunshine Act without significant expansion.”
Those interpretations include applicable manufacturers; covered drugs, devices, biological or medical supplies; covered recipients; and payment or other transfers of value.
“The two categories of information that must be reported under the Sunshine Act are reports from applicable manufacturers on payments or other transfers of value to covered recipients; and reports from applicable manufacturers and applicable GPOs concerning ownership and investment interests of physicians and their immediate family members, as well as information on any payments or other transfers of value provided to such physician owners or investors,” said Kannensohn. “While CMS admits there’s some overlap between these two submissions, CMS proposes that the information be reported separately to ensure that relevant reporting obligations of applicable manufacturers and applicable GPOs are clearly distinguished. CMS is seeking comments on this general approach.”
Also addressed in the Sunshine Act Proposed Rule:
Nature of payment: charitable contributions, meals, research and speaking engagements;
Reports of physician ownership and investment interests;
Reporting mechanics;
Penalties;
Annual reports; and
State law preemption.
“The Sunshine Act preempts any state or local laws requiring reporting, in any format, of the same type of information concerning payment or other transfers of value made by applicable manufacturers to covered recipients,” said Werling. “In general, no state or local government may require the separate reporting of any information regarding a payment or other transfer of value that’s required to be reported under the Sunshine Act.”
However, Carnell noted, the Sunshine Act doesn’t preempt any statute or regulation of a state that requires the reporting of information by any person or entity other than an applicable manufacturer or the reporting of information to a person or entity other than a covered recipient, and the reporting of information not of the type required to be reported under the Sunshine Act.
Digg
Facebook
Technorati
Newsvine
Google
